Summary
The FDA issued a Class II for Bicarby Dialysate; Model number: RFP-400-G; by Fresenius Medical Care Holdings, Inc.. Reason: There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the produc.
Details
Source
Device Recall
External ID
Z-2401-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
Product Description
Bicarby Dialysate; Model number: RFP-400-G;
Lot/Code Info: Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
Quantity Affected: 4752
Reason for Recall
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
Distribution
Domestic: TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-07
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Medical Care Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Holdings, Inc. have FDA actions?
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2401-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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